LegalizeCommission Regulation (EU) No 885/2010 of 7 October 2010 concerning the authorisation of the preparation of narasin and nicarbazin as a feed additive for chickens for fattening (holder of authorisation Eli Lilly and Company Ltd) and amending Regulation (EC) No 2430/1999 Text with EEA relevance
Article 1
The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
In Annex I to Regulation (EC) No 2430/1999, the entry under the registration number of additive E 772, concerning Narasin 80 g/kg — Nicarbazin 80 g/kg (Maxiban G160), is deleted.
Premixture and compound feed containing the feed additive labelled in accordance with Regulation (EC) No 2430/1999 may continue to be placed on the market and remain on the market and used until stocks are exhausted.
Article 3
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation | Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin |
|---|---|---|---|---|---|---|---|---|---|---|
| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % | ||||||||||
| Coccidiostats and histomonostats | ||||||||||
| 5 1 772 | Elanco GmbH | Narasin 80 g activity/kg Nicarbazin 80 g/kg (Maxiban G160) | Additive composition Narasin: 80 g activity/kg Nicarbazin: 80 g/kg (Ratio 1:1) Vegetal or mineral oil: 10-30 g/kg Vermiculite: 0-20 g/kg Micro tracer red: 4-11 g/kg Corn cob grits or rice hulls qs 1 kg Active substance 1. Narasin, C43H72O11 CAS number: 55134-13-9 polyether monocarboxylic acid produced by Streptomyces aureofaciens (NRRL 8092), in granular form Narasin A activity: ≥ 85 % 2. Nicarbazin, C19H18N6O6. CAS number: 330-95-0 equimolecular complex of 1,3-bis(4-nitrophenyl) urea and 4,6 dimethylpyrimidin-2-ol, in granular form Related impurities: p-nitroaniline: ≤ 0,3 % Analytical methods (1) For the determination of narasin: reversed-phase high performance liquid chromatography (HPLC) using post-column derivatisation with vanillin and detection at 520 nm - ISO 14183:2005. For determination of nicarbazin: high performance liquid chromatography method and ultraviolet detection (HPLC-UV) spectrometry (LC-MS/MS) | Chickens for fattening | — | 40 mg Narasin 40 mg Nicarbazin | 50 mg Narasin 50 mg Nicarbazin | 1. Indicate in the instructions for use: ‘Dangerous for equine species, turkeys and rabbits’ ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated’. 2. The additive shall be incorporated in compound feed in form of a premixture. 3. The preparation of narasin and nicarbazin shall not be mixed with other coccidiostats. 4. A post-market monitoring program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation. 5. From 28 October 2013 the p-nitroaniline content shall be ≤ 0,1 %. 6. For safety: breathing protection shall be used during handling. | 28 October 2020 | 50 μg of narasin/kg for fresh liver, muscle, kidney and skin/fat. 15 000 μg of dinitrocarbanilide (DNC)/kg of fresh liver; 6 000 μg of DNC/kg of fresh kidney; 4 000 μg of DNC/kg for fresh muscle and fresh skin/fat. |
| (1) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives |
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